AZATHIOPRINE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

AZATHIOPRINE (UNII: MRK240IY2L) (AZATHIOPRINE - UNII:MRK240IY2L)

متاح من:

Aphena Pharma Solutions - Tennessee, LLC

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

INDICATIONS AND USAGE: Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been

ملخص المنتج:

HOW SUPPLIED: Azathioprine Tablets, USP, 50 mg are capsule-shaped, yellow, scored tablets, bottles of 100 (NDC 51407-182-01) Rx only. Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature] Store in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AZATHIOPRINE- AZATHIOPRINE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
AZATHIOPRINE TABLETS, 50 MG
WARNING: _MALIGNANCY_Chronic immunosuppression with this purine
antimetabolite
increases _risk of malignancy _in humans. Reports of malignancy
include post-transplant lymphoma
and hepatosplenic T-cell lymphoma (HSTCL) in patients with
inflammatory bowel disease.
Physicians using this drug should be very familiar with this risk as
well as with the mutagenic
potential to both men and women and with possible hematologic
toxicities. Physicians should
inform patients of the risk of malignancy with azathioprine. See
WARNINGS.
DESCRIPTION:
Azathioprine, an immunosuppressive antimetabolite, is available in
tablet form for oral administration.
Each scored tablet contains 50 mg azathioprine and the inactive
ingredients lactose monohydrate,
pregelatinized starch, povidone, corn starch, magnesium stearate, and
stearic acid.
Azathioprine is chemically 1H-purine, 6-[(1-methyl-4-nitro-
1H-imidazol-5-yl)thio]-. The structural
formula of azathioprine is:
It is an imidazolyl derivative of 6-mercaptopurine and many of its
biological effects are similar to those
of the parent compound.
Azathioprine is insoluble in water, but may be dissolved with addition
of one molar equivalent of alkali.
Azathioprine is stable in solution at neutral or acid pH but
hydrolysis to mercaptopurine occurs in
excess sodium hydroxide (0.1N), especially on warming. Conversion to
mercaptopurine also occurs in
the presence of sulfhydryl compounds such as cysteine, glutathione,
and hydrogen sulfide.
CLINICAL PHARMACOLOGY:
Azathioprine is well absorbed following oral administration. Maximum
serum radioactivity occurs at 1
to 2 hours after oral
S-azathioprine and decays with a half-life of 5 hours. This is not an
estimate of
the half-life of azathioprine itself but is the decay rate for all
S-containing metabolites of the drug.
Because of extensive metabolism, only a fraction of the radioactivity
is present as azathioprine. Usual
doses produce blood